Immunomedics, Inc.

Director, IT Computer System Validation (CSV)

Job Locations US-NJ-Morris Plains
Posted Date 1 month ago(4/23/2020 12:04 PM)
Job ID
2020-1677
# of Openings
1
Category
Information Technology

Overview

Responsible to define, maintain and oversee the IT strategy regarding adherence to applicable global regulatory requirements (i.e. 21 CFR Part 11, Annex 11). This position will provide partnership across the business (i.e. Manufacturing, Quality, Validation, Compliance, etc.) through quality management and quality oversight activities intended to ensure overall global regulatory adherence. This includes partnering with key business stakeholders in the development of the computer system validation corporate strategy, provide subject matter expertise and lead the IT component of the corporate wide CSV program. Provide CSV expertise while working closely with the validation and quality teams to deliver on key elements of the quality and compliance programs in support of business objectives.

This position will have responsibility and ownership of all IT CSV related policies and procedures, including the CSV Master Plan, ensuring they meet organization needs and remain aligned to global regulatory guidance. This activity includes partnering with corporate training to ensure the organization is properly trained on CSV concepts, policies, processes and procedures.

Responsibilities

  • Partner with key business stakeholders to develop the corporate strategy and associated policy and procedures necessary to guide the implementation and maintenance of a compliant, efficient and integrated CSV program.
  • Provide proactive quality support regarding best practices, document management, process development/improvement and risk management for computer systems
  • Determine the appropriate level of qualification and validation necessary for electronic systems and engineering tools to ensure compliance with relevant global regulations and industry guidance documents. Design, implement and oversee risk-based computer systems validation activities (e.g., specifications, testing, qualification, release). Guide and reconcile any associated corrective and preventive actions needed to ensure compliance.
  • Provide hands-on project management and support to ensure the completion of computer system validation and the associated documentation (e.g. plans, protocols, reports, memos)
  • Foster a quality culture focused on meeting high quality, ethical and compliance standards.
  • Enhance and implement document management and training plans for a compliant approach to the software development lifecycle (SDLC)
  • Design, implement and oversee compliance training
  • Ensure proactive audits/inspection readiness in partnership with business stakeholders Participate in audits/inspections, both internal and external, representing Computer System Validation methodologies, processes, procedures and systems
  • Plan, complete, document and closure audits of IT supply vendors
  • Collaborate with internal and external partners to advise on the correct application of internal and external requirements for computer systems projects
  • Maintain and implement the quality systems to ensure compliance with applicable global regulatory requirements. Assess and manage internal compliance with the quality systems
  • Establish working partnership with key business stakeholders (i.e. Quality, Validation, etc.) to drive definition and implementation of CSV strategy
  • Participate and network in the external industry forums and conferences to influence and contribute to internal computer system validation practices

Qualifications

  • Bachelors’ degree in Computer Science, Business or closely related field from accredited college or university, or equivalent experience
  • Minimum 5 years of direct experience with completion of day to day validation activities in a pharmaceutical/biotech environment
  • Minimum of 10 years leading or managing CSV teams or functions in a highly regulated environment
  • Strong knowledge of global Supply Chain, Manufacturing, and Quality operations and processes
  • Extensive and detailed knowledge of current GxP (e.g. Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, etc.) Computer System Validation, regulatory requirements and GAMP 5 for a global operation.
  • A thorough understanding of drug development processes from discovery through development and post-marketing, with an ability to understand business requirements and translate them into practical solutions
  • Advanced communication and presentation skills with an ability to adjust to both technical and non-technical audiences including business stakeholders and senior management
  • Ability to manage competing demands in a fast-paced, dynamic environment where collaboration, communication, prioritization, and flexibility are key attributes for success
  • Experience managing multiple projects, including partnerships with external partners, simultaneously from design through deployment
  • A proven track record in delivering change and transformation projects and their associated benefits to an agreed time-line, budget and quality
  • Certification / experience in Operational Excellence / Six Sigma highly desired
  • CSV and CSV related certifications (e.g. CSTE, CSTP, CQSA, etc.) are highly desired
  • Extensive experience working within a highly regulated environment (e.g. licensed laboratory, commercial manufacturing, R&D, life sciences)
  • Proactive quality support methodology that can translate complex regulatory principles into best practices for cross-functional teams
  • Strong working knowledge of global regulations for electronic systems validation (i.e. 21 CFR Part 11, Annex 11) coupled with ability to practically apply such knowledge
  • Experience in developing an organizational “culture of quality” and risk-based validation activities
  • Experience drafting, reviewing, implementing and ensuring compliance with validation procedures that drive efficiency and foster a creative approach to solving business needs
  • Ability to work within cross-functional teams and manage/drive multiple simultaneous validation projects
  • Excellent communication and listening skills
  • Strategic thinker with ability to articulate vision and execute well
  • Strong and proven leadership, influencing, persuasion and negotiation skills.
  • Proven ability to build and maintain strong collaborative relationships across the business.
  • Ability to quickly adapt to changing priorities, assignments and roles.
  • Effective change agent – Understanding the importance of change management and the critical role that well-timed communication plays in driving change
  • Direct experience as a computer systems validation auditor is a plus

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed